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Serving 500+ biopharmaceutical companies globally:

Julphar
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Fish and Richardson
Healthtrust
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Daiichi Sankyo
Express Scripts
Cipla
QuintilesIMS
Queensland Health

Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090951

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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Akorn, Breckenridge Pharm, and Sandoz Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for NDA: 090951

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 090951

Suppliers and Packaging for NDA: 090951

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 090951 ANDA Somerset Therapeutics, LLC 70069-008 70069-008-10 10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Argus Health
AstraZeneca
McKinsey
Citi
McKesson
Fuji
Federal Trade Commission
Medtronic
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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